Medical device registration in Azerbaijan has been mandatory since 2024. Under Resolution No. 345 of the Cabinet of Ministers, dated July 18, 2024, the import, production, and sale of medical devices is permitted only after state registration.<\/p>\n
This guide covers the full process \u2014 which devices require registration, the documents you need, each stage of the procedure, realistic timelines, and how professional support can streamline everything.<\/p>\n
Previously, medical devices could be imported and marketed in Azerbaijan without registration. That changed with Law No. 979-VIQD of July 14, 2023, which amended the Law of the Republic of Azerbaijan “On Medicinal Products.”<\/p>\n
As of July 19, 2024, all medical devices \u2014 except those classified as Risk Class I \u2014 require state registration before they can be imported, produced, sold, or used in the country.<\/p>\n
The responsible regulatory body is the Analytical Expertise Center (AEC)<\/strong><\/a> under the Ministry of Health of the Republic of Azerbaijan.<\/p>\n Decision No. 8 of the Ministry of Health, dated May 21, 2024, classifies medical devices by risk level:<\/p>\n Important:<\/strong> Azerbaijan’s risk classification system differs significantly from both the European Union and U.S. frameworks. Each device’s risk class must be determined according to Azerbaijani legislation, regardless of its classification in the country of origin.<\/p>\n To obtain state registration, the applicant must submit the following to the Analytical Expertise Center:<\/p>\n If CE\/EAC markings are present<\/strong> on the device, a declaration of conformity must also be submitted.<\/p>\n The first step is to correctly determine the device’s risk class under Azerbaijani legislation. This is the most critical stage \u2014 incorrect classification can result in rejection and force the entire process to restart.<\/p>\n Technical documentation is reviewed and adapted to Azerbaijani requirements. User manuals are translated into Azerbaijani with notarization. Packaging mock-ups are prepared. Certain documents require notarized certification.<\/p>\n Note:<\/strong> Documents may be submitted in Russian, English, or Azerbaijani, but the instructions for use must be in Azerbaijani.<\/p>\n The completed dossier is submitted to the Analytical Expertise Center. The AEC conducts an examination and may request additional documents or clarifications.<\/p>\n Upon successful completion of the examination, a separate registration certificate is issued for each medical device. The certificate is valid for 5 years.<\/strong> Re-registration applications must be submitted at least 90 calendar days before the current registration expires.<\/p>\n Post-marketing requirements:<\/strong> Currently, the regulator does not require routine post-marketing reports. However, serious and unexpected adverse events must be reported within 3 days. These requirements are expected to expand in the future.<\/p>\n Timelines depend on the completeness of the document package and the number of additional queries from the AEC.<\/p>\n For medical devices imported from China, Turkey, Europe, or other countries, additional considerations apply:<\/p>\n The most common issues encountered during medical device registration in Azerbaijan include:<\/p>\n Professional regulatory support minimizes these risks, ensures first-submission acceptance of documents, and can reduce the overall timeline by 30\u201350%.<\/p>\n Registration is not required for Risk Class I devices. However, a one-time import permit must be obtained from the AEC for each batch.<\/p>\n The registration certificate is valid for 5 years. Re-registration applications must be submitted at least 90 calendar days before the certificate expires.<\/p>\n Documents may be submitted in Russian, English, or Azerbaijani. However, the instructions for use (user manual) must be in Azerbaijani.<\/p>\n Currently, the regulator does not mandate routine post-marketing reports, pharmacovigilance system establishment, or electronic system filings. However, all serious and unexpected adverse events must be reported to the competent authority within 3 days. These requirements are expected to be expanded in the future.<\/p>\n Yes \u2014 provided the manufacturer’s document confirming the device’s suitability for use is notarized and translated into Azerbaijani with notarization.<\/p>\n Not necessarily. Azerbaijan adopted its own national classification system through Ministry of Health Decision No. 8 (May 21, 2024) and Decision No. 9 (list of devices by risk level). Your device’s risk class must be determined according to Azerbaijani legislation.<\/p>\nWhich Medical Devices Require Registration?<\/h2>\n
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Documents Required for Registration<\/h2>\n
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Steps of the Registration Process<\/h2>\n
Step 1 \u2014 Classification and Assessment<\/h3>\n
Step 2 \u2014 Document Preparation and Localization<\/h3>\n
Step 3 \u2014 Submission to AEC and Examination<\/h3>\n
Step 4 \u2014 Issuance of Registration Certificate<\/h3>\n
Timelines and Timeframes<\/h2>\n
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\n \nStage<\/th>\n Estimated Duration<\/th>\n<\/tr>\n<\/thead>\n \n Document preparation<\/td>\n 2\u20134 weeks<\/td>\n<\/tr>\n \n AEC examination<\/td>\n 1\u20132 months<\/td>\n<\/tr>\n \n Total process<\/td>\n 1.5\u20133 months<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n Special Requirements for Foreign Companies<\/h2>\n
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Why Professional Support Makes a Difference<\/h2>\n
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Frequently Asked Questions<\/h2>\n
What is required for Risk Class I devices?<\/h3>\n
How long is the registration certificate valid?<\/h3>\n
In which languages are documents accepted?<\/h3>\n
Are post-marketing reports required?<\/h3>\n
Can used medical equipment be registered?<\/h3>\n
Does the risk class from my country apply in Azerbaijan?<\/h3>\n
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